YASMIN- drospirenone and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

DROSPIRENONE

Composition:

DROSPIRENONE 3 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Yasmin® is indicated for use by females of reproductive potential to prevent pregnancy. Yasmin is contraindicated in females who are known to have or develop the following conditions: There is no use for contraception in pregnancy; therefore, Yasmin should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth w

Product summary:

Yasmin (drospirenone/ethinyl estradiol) tablets are available in packages of three blister packs (NDC 50419-402-03). The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with DO or DP. Each blister pack contains 28 film-coated tablets in the following order: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

YASMIN- DROSPIRENONE AND ETHINYL ESTRADIOL
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
YASMIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YASMIN.
YASMIN (DROSPIRENONE/ETHINYL ESTRADIOL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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•
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 5/2023
INDICATIONS AND USAGE
Yasmin is a combination of drospirenone, a progestin, and ethinyl
estradiol, an estrogen, indicated for use
by females of reproductive potential to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
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•
DOSAGE FORMS AND STRENGTHS
Yasmin consists of 28 film-coated, biconvex tablets in the following
order (3):
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•
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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•
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE YASMIN. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
Dosage and Administration (2.3) 5/2023
Warnings and Precautions, (5.11) Removed 5/2023
Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the blister pack. (2.1)
21 yellow tablets, each containing 3 mg drospirenone (DRSP) and 0.03
mg ethinyl estradiol (EE)
7 inert white tablets
Renal impairment (4)
Adrenal insufficiency (4)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Liver tumors or liver disease (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir, paritaprevir/ritonavir, with
or without dasabuvir (4)
Vascular risks: Stop Yasmin if a thrombotic event occurs. Stop at
least 4 weeks before and through 2
weeks after major surgery. Start no earlier than 4 weeks after
delivery, in women who are not
breastfeeding (5.1